- Role
- Country
- Date of registration
- Address
US-MF-000018839No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Healgen Scientific Limited Liability Company. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 1, 2026
B-GCCr(Ag)-402aHGDPPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-GCCr(Ag)-402aHGDP
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
3 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW007Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-GCCr(Ag)-402aHGDPBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-GCCr(Ag)-402aHGDPGCCr(Ag)-402aUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105060303CRYPTOCOCCUSB-FDWCR-PN20HGR8On the marketCRP Quantitative Test Kit (Time-Resolved FIA)B-FDWCR-402aHGAZOn the marketCRP/SAA ControlB-FDCS-PN20HG35On the marketCT ControlB-FDCT-PN20HG3QOn the marketcTnI ControlB-FDTRO-PN20HGXHOn the marketcTnI Quantitative Test Kit (Time-Resolved FIA)B-FDTRO-402bHGHFOn the marketNo certificate specifically references this device's Basic UDI-DI.